Just one minor comment Thur Low...
Your statement "...there will be continual minor adjustments to both the device and the conduct of the trials..." is not strictly correct. The nature of a clinical trial is such that conditions of the trial may NOT be changed during the trial. The procedures must all have been approved by various bodies including a human ethics committee prior to permission for the trial being granted. Once established, these conditions must remain constant or the trial becomes invalid.
Hope this helps...
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